Videx EC 250 mg

Videx EC 400 mg

What is the most important information I should know about didanosine?

You should not use didanosine if you are allergic to it. Do not take didanosine together with allopurinol (Zyloprim) or ribavirin (Rebetol, Ribasphere, Copegus, Virazole).

Some people develop lactic acidosis while taking didanosine. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Didanosine can also cause severe or life-threatening effects on your liver or pancreas. Call your doctor at once if you have any of these symptoms while taking didanosine: severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Do not take didanosine without telling your doctor if you are pregnant. Lactic acidosis or liver problems caused by didanosine can be very dangerous during pregnancy.

What is didanosine?

Didanosine is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Didanosine is not a cure for HIV or AIDS.

Didanosine may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking didanosine?

You should not use didanosine if you are allergic to it. Do not take didanosine together with allopurinol (Zyloprim) or ribavirin (Rebetol, Ribasphere, Copegus, Virazole).

Some people develop a life-threatening condition called lactic acidosis while taking didanosine. You may be more likely to develop lactic acidosis if you are overweight or have liver disease, if you are a woman, or if you have taken HIV or AIDS medications for a long time. Talk with your doctor about your individual risk.

Didanosine can also cause severe or life-threatening effects on your liver or pancreas. Tell your doctor if you have liver disease or a history of pancreatitis.

To make sure you can safely take didanosine, tell your doctor if you have any of these other conditions:

liver disease;

kidney disease (or if you are on dialysis);

a history of numbness or tingling in your hands or feet, including Raynaud's syndrome; or

a history of pancreatitis;

if you also take stavudine (Zerit).

Do not take didanosine without telling your doctor if you are pregnant. Lactic acidosis or liver problems caused by didanosine can be very dangerous during pregnancy.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of didanosine on the baby.

Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

How should I take didanosine?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take didanosine on an empty stomach, at least 1 hour before or 2 hours after a meal. Do not take with food.

Do not crush, chew, break, or open a delayed-release capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

HIV/AIDS is usually treated with a combination of different drugs. Certain HIV medications or antibiotics should not be taken at the same time as didanosine because they can affect the levels of this medicine in your blood stream:

ciprofloxacin (Cipro) should be taken at least 2 hours before or 6 hours after you take didanosine.

delavirdine (Rescriptor) or indinavir (Crixivan) should be taken at least 1 hour before you take didanosine.

nelfinavir (Viracept) should be taken at least 1 hour after you take didanosine.

itraconazole (Sporanox) or ketoconazole (Nizoral) should be taken at least 2 hours before you take didanosine.

Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

To be sure this medication is not causing harmful effects, your blood may need to be tested often. Your vision, kidney function, and liver function may also need to be tested. Do not miss any follow up visits to your doctor for blood or urine tests.

Store the tablets or capsules at room temperature in a tightly closed container, away from moisture and heat.

Store the liquid form of didanosine in the refrigerator. Throw away any leftover didanosine liquid that is more than 30 days old.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include some of the serious side effects listed in this medication guide.

What should I avoid while taking didanosine?

Do not drink alcohol. It may increase your risk of liver damage or pancreatitis.

Avoid using antacids without your doctor's advice while taking didanosine. Use only the specific type of antacid your doctor recommends.

Taking this medication will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

What are the possible side effects of didanosine?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Didanosine may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as:

muscle pain or weakness;

numb or cold feeling in your arms and legs;

trouble breathing;

feeling dizzy, light-headed, tired, or very weak;

stomach pain, nausea with vomiting; or

fast or uneven heart rate.

Stop using didanosine and call your doctor at once if you have any of these other serious side effects:

signs of a new infection such as flu symptoms, easy bruising or unusual bleeding, loss of appetite, mouth sores;

problems with walking, breathing, speech, swallowing, or eye movement; or

severe lower back pain, loss of bladder or bowel control.

Less serious side effects may include:

mild skin rash;

diarrhea;

headache; or

changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect didanosine?

Tell your doctor about all other medicines you use, especially:

ganciclovir (Cytovene);

hydroxyurea (Droxia, Hydrea);

methadone (Diskets, Dolophine, Methadose); or

tenofovir (Viread, Atripla, Complera, Truvada).

This list is not complete and other drugs may interact with didanosine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about didanosine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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